Evaluation of a computerized diagnostic decision support system for patients with pneumonia: study design considerations.

Planning the clinical evaluation of a computerized decision support system requires a strategy that encompasses the different aspects of the clinical problem, the technical difficulties of software and hardware integration and implementation, the behavioral aspects of the targeted users, and the discipline of study design. Although clinical information systems are becoming more widely available, only a few decision support systems have been formally evaluated in clinical environments. Published accounts of difficulties associated with the clinical evaluation of decision support systems remain scarce. The authors report on a variety of behavioral, logistical, technical, clinical, cost, and work flow issues that they had to address when choosing a study design for a clinical trial for the evaluation of an integrated, real-time decision support system for the automatic identification of patients likely to have pneumonia in an emergency department. In the absence of a true gold standard, they show how they created a credible, clinically acceptable, and economical reference standard for the diagnosis of pneumonia, to determine the overall accuracy of the system. For the creation of a reference standard, they describe the importance of recognizing verification bias and avoiding it. Finally, advantages and disadvantages of different study designs are explored with respect to the targeted users and the clinical setting.